filmov
tv
eCTD 4.0: What is Changing (with Paul Ireland - VP Life Sciences @docshifter )
Показать описание
00:00 - Welcome & Introductions
2:22 - What is eCTD 4.0?
4:00 - What makes eCTD 4.0 from previous versions?
7:50 - Why is the move to eCTD 4.0 so crucial?
9:37 - By when do we need to be ready?
12:48 - Main benefits for the sponsor organisations
14:27 - How will it affect the content required for a submission?
15:50 - Are there any drawbacks to eCTD 4.0?
#####
eCTD 4 is a long-awaited topic. What is going to change? Should we be afraid? When are the health authorities implementing the eCTD v4.0 format?
It brings many questions along. And a few key improvements to:
- Document re-use
- Controlled vocabularies
- A new XML schema
- Communication between health authorities and sponsors
Following our article in the Regulatory Professionals Community, we are now hosting an 'Ask the expert' session to talk about eCTD 4.0.
2:22 - What is eCTD 4.0?
4:00 - What makes eCTD 4.0 from previous versions?
7:50 - Why is the move to eCTD 4.0 so crucial?
9:37 - By when do we need to be ready?
12:48 - Main benefits for the sponsor organisations
14:27 - How will it affect the content required for a submission?
15:50 - Are there any drawbacks to eCTD 4.0?
#####
eCTD 4 is a long-awaited topic. What is going to change? Should we be afraid? When are the health authorities implementing the eCTD v4.0 format?
It brings many questions along. And a few key improvements to:
- Document re-use
- Controlled vocabularies
- A new XML schema
- Communication between health authorities and sponsors
Following our article in the Regulatory Professionals Community, we are now hosting an 'Ask the expert' session to talk about eCTD 4.0.
0:20:42
eCTD 4.0: What is Changing (with Paul Ireland - VP Life Sciences @docshifter )
0:46:23
Electronic Common Technical Document (eCTD)
0:00:55
Recommendations on How to Adopt eCTD 4.0 | Freyr Solutions
0:23:45
eCTD Submission Challenges
0:11:06
Regulatory Affairs Explained Series Episode 4 | Electronic Common Technical Document (eCTD) Modules
0:00:48
eCTD submission: Submission Regulatory and Procedural Guidance Video
0:20:18
eCTD Submissions of Promotional Labeling and Advertising Materials
1:01:36
eCTD in Australia. (AU- TGA) now recommeds eCTD submissions
0:29:03
eCTD Global Aspects and Future Directions (LinkedIn Live with LORENZ Life Sciences Group)
0:00:57
#𝐬𝐡𝐨𝐫𝐭𝐬 #𝐞𝐂𝐓𝐃 #𝐞𝐂𝐓𝐃𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 #𝐞𝐂𝐓𝐃𝐦𝐨𝐝𝐮𝐥𝐞𝐬 𝐄𝐥𝐞𝐜𝐭𝐫𝐨𝐧𝐢𝐜 𝐂𝐨𝐦𝐦𝐨𝐧 𝐓𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭 (𝐂𝐓𝐃)...
0:25:03
Regulatory Updates, 2015
1:24:57
EU Variation Overview Regulatory Lectures by Rajashri Ojha at Raaj Pharmaelearning
0:00:43
why the regulatory intelligence is needed?
0:49:36
Advantages of CTD eCTD organization-A lecture 2021 by Rajashri Ojha
0:22:51
ctd ectd edited video by Mrs.Rajashri Ojha (Founder & Director of RaajGPRAC)
0:00:58
changing output format of a seabird ctd
0:28:11
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
0:03:32
About FDA’s Data Standards Program
0:00:16
Need a one-off sequence?
0:23:10
What’s New for SEND 2023 Webinar
0:07:34
What is CATT? CBER Advanced Technologies Team
1:48:07
PharmaFORUM Webcast International 'eCTD worldwide' 5 July 2018
1:00:38
ECT-Balancing Evidence and Practice | #eastwestpharma
0:58:43
So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020
Комментарии